The following data is part of a premarket notification filed by E-z Kare Good Health Systems, Inc. with the FDA for E-z Breathers.
| Device ID | K953042 |
| 510k Number | K953042 |
| Device Name: | E-Z BREATHERS |
| Classification | Dilator, Nasal |
| Applicant | E-Z KARE GOOD HEALTH SYSTEMS, INC. P.O. BOX 11 Tavares, FL 32778 |
| Contact | Bret Cipes |
| Correspondent | Bret Cipes E-Z KARE GOOD HEALTH SYSTEMS, INC. P.O. BOX 11 Tavares, FL 32778 |
| Product Code | LWF |
| CFR Regulation Number | 874.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-15 |
| Decision Date | 1995-12-08 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() E-Z BREATHERS 75084118 not registered Dead/Abandoned |
EZ Kare Good Health Systems, Inc. 1996-04-05 |